Effect of food on the pharmacokinetics of zoliflodacin granules for oral suspension: Phase I open-label randomized cross-over study in healthy subjects

by Luckey A, Alirol E, Delhomme S, O’Donnell J, Bettiol E, Mueller J, O’Brien S, Gillon J-Y. Clinical and Translational Science 2023, 16(5): 770-780. doi: doi.org/10.1111/cts.13487

Summary: The range of treatment options for the sexually transmitted infection gonorrhea has reduced due to increasing antibiotic resistance. The authors describe the results of a phase I study in healthy adults to evaluate the effect of food on the pharmacokinetics of zoliflodacin, an oral antibacterial agent being developed for uncomplicated gonorrhea, in the fasted state or after consumption of a standardized high-fat meal. Administration of single 3 and 4 g doses of zoliflodacin (as granules for oral suspension) with a high-fat meal was well-tolerated and resulted in a statistically significant increase in peak and overall systemic exposure to zoliflodacin.

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